Surgical wound closure is currently achieved by sutures and staples that facilitate healing by pulling tissues together. However, very often they fail to produce the complete seal necessary to prevent bleeding and fluid leakage. Thus, there is a large, unmet medical need for devices and methods to prevent bleeding and leakage during and following surgery, including leaks that frequently occur along staple and suture lines. Such devices and methods are needed as an adjunct to sutures or staples to achieve hemostasis or other fluid-stasis in peripheral vascular reconstructions, dura reconstructions, thoracic, cardiovascular, lung, neurological, and gastrointestinal surgeries.
In addition to surgery, the control of hemorrhage (bleeding) is a critical step in first aid and field trauma care.
A wide range of products have been suggested as solutions for hemostasis and fluid stasis both as first aid and as surgical devices. However, existing products comprise limited or partial solutions that frequently have significant drawbacks.
As an example of non-optimal hemostasis products: currently no commercially available device involving cross-linked gelatin networks has been able to independently induce hemostasis for brisk internal bleeding, even with the addition of thrombin. A study was done comparing the hemostatic capacity of FloSeal gelatin matrix (BioSurgery, Fremont, Calif.) and GelFoam gelatin matrix soaked in active thrombin solution. Neither enhanced hemostatic device was able to stop flow characterized bleed in more than ⅔ of patients after 5 minutes. Pulsatile arterial bleeding is far more brisk than flow bleeding and would most certainly present a problem for these thrombin-soaked matrices (F A Weaver et al. (2002). Ann Vasc Surg 16(3):286-93).
In any case, there remains a distinct deficiency in trauma and surgical care, in that there is no novel, active hemostatic field dressing or surgical dressing that is commercially available which can control hemorrhage and fluid leakage without significant side effects. Similarly, there remains a distinct deficiency in surgical care, in that there is no commercially available non-toxic sealant that is capable of withstanding brisk bleeding and able to seal wound sites leaking non-blood body fluids.